Regulatory Affairs Specialist for Medical Devices

5 days ago


Dublin, Dublin City, Ireland Vectura Group Full time
Job Summary

We are seeking an experienced Regulatory Affairs Specialist to contribute to our regulatory activities, ensuring the successful and timely approval of relevant medical device submissions.

This role will ensure global regulatory compliance while supporting Vectura's corporate goals. The successful candidate will provide strategic regulatory guidance for medical device development and new product evaluations, ensuring seamless collaboration between regulatory, quality assurance, and device engineering teams.

Key Responsibilities:
  • Contribute to the regulatory strategy and global approval process for medical devices.
  • Prepare final regulatory documentation and manage communications with regulatory authorities and notified bodies.
  • Lead or support key regulatory projects, including EUDAMED implementation, QSMR, UKCA compliance, and development devices.
  • Maintain and archive device registrations while ensuring compliance with relevant standards and legal requirements.
  • Support development activities, including risk management documentation, DHF maintenance, and the creation of IFUs and labels.
  • Develop regulatory strategies for clinical trials and commercial activities, ensuring compliance with language requirements, local legislation, and registrations.
  • Assist regulatory affairs for medicinal products in the submission of drug-device combination products, either in collaboration with partners/customers or for internal proprietary programs.
  • Identify and analyse the impact of new or revised standards and legal requirements.
  • Contribute to the company's Regulatory Newsletter as needed.
  • Assist in the planning, execution, and documentation of verification and validation activities.
Education & Experience Requirements:
  • Significant experience in medical device regulatory affairs, including industry and/or regulatory agency/notified body experience.
  • Strong understanding and ability to interpret medical device regulations and guidelines, including CFRs, MDD, ISO 13485, EN 60601-1, EN 14971, and EU MDR.
  • In-depth knowledge of medical device regulatory guidelines and standards related to drug delivery.
  • A relevant university degree (engineering, life sciences, or equivalent) OR approximately 5 years of professional experience in regulatory affairs or quality management systems related to medical devices.
  • Experience engaging with Regulatory Authorities (e.g., FDA, Notified Bodies).
  • Strong ability to work independently, manage multiple projects, and meet deadlines.
Why Choose Vectura Group?

We offer a dynamic and innovative work environment where you can make a meaningful impact in healthcare. As a Regulatory Affairs Specialist, you will have the opportunity to work on cutting-edge medical devices and combination products, collaborating with experts in regulatory affairs, quality assurance, and device engineering.



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